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<p>The EXTRA trial was the first to identify predictive biomarkers for afatinib efficacy in <i>epidermal growth factor receptor (EGFR)</i>-mutant NSCLC. We analyzed the clinical data of older adult patients before translational analysis. This prospective study involved untreated patients with EGFR-mutant NSCLC who received afatinib at an initial dose of 40&#xa0;mg/day, followed by stepwise dose reductions, ultimately reaching 20&#xa0;mg administered every other day. Treatment efficacy and adverse events (AEs) were compared between non-older and older adult patients. Among the 103 patients, 71 were aged &lt; 75&#xa0;years, and 32 were aged ≥ 75&#xa0;years. Despite increased dose reductions in the older adults, progression-free survival was comparable: 21.5 vs. 18.6&#xa0;months for non-older and older adults, respectively. The median overall survival (OS) was not reached in either group; the 2-year OS rates were 82% and 75% in non-older and older adults, respectively. Median post-progression survival in patients administered second-line drug therapy was 14.3 and 11.2&#xa0;months in non-older (<i>n</i> = 42) and older adults (<i>n</i> = 20), respectively. Among older adults, 31 (97%) patients experienced AEs of all grades, and only six patients had grade ≥ 3 AEs with no grade 5 AEs. Afatinib demonstrated comparable therapeutic efficacy and safety in older and non-older adult patients with advanced <i>EGFR</i>-mutant NSCLC.</p><p><b>Trial registration</b>: UMIN-CTR identifier (UMIN000024935)</p>

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Efficacy and safety findings of the EXTRA study in older adult EGFR-mutant lung cancer patients receiving afatinib as first-line treatment

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月11日

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  • Kei Morikawa,
  • Saori Takata,
  • Hisashi Tanaka,
  • Hidetoshi Itani,
  • Masashi Ishihara,
  • Kazuya Horiuchi,
  • Yasuhiro Kato,
  • Shinnosuke Ikemura,
  • Hideyuki Nakagawa,
  • Yoshiro Nakahara,
  • Yoshitaka Seki,
  • Akihiro Bessho,
  • Nobumasa Takahashi,
  • Kentaro Hayashi,
  • Takeo Endoh,
  • Kiyoshi Takeyama,
  • Toshiya Maekura,
  • Nagio Takigawa,
  • Akikazu Kawase,
  • Makoto Endoh,
  • Kenji Nemoto,
  • Kazuma Kishi,
  • Kenzo Soejima,
  • Yusuke Okuma,
  • Kenichi Yoshimura,
  • Daisuke Saigusa,
  • Yae Kanai,
  • Koji Ueda,
  • Akira Togashi,
  • Noriyuki Matsutani,
  • Nobuhiko Seki

摘要

The EXTRA trial was the first to identify predictive biomarkers for afatinib efficacy in epidermal growth factor receptor (EGFR)-mutant NSCLC. We analyzed the clinical data of older adult patients before translational analysis. This prospective study involved untreated patients with EGFR-mutant NSCLC who received afatinib at an initial dose of 40 mg/day, followed by stepwise dose reductions, ultimately reaching 20 mg administered every other day. Treatment efficacy and adverse events (AEs) were compared between non-older and older adult patients. Among the 103 patients, 71 were aged < 75 years, and 32 were aged ≥ 75 years. Despite increased dose reductions in the older adults, progression-free survival was comparable: 21.5 vs. 18.6 months for non-older and older adults, respectively. The median overall survival (OS) was not reached in either group; the 2-year OS rates were 82% and 75% in non-older and older adults, respectively. Median post-progression survival in patients administered second-line drug therapy was 14.3 and 11.2 months in non-older (n = 42) and older adults (n = 20), respectively. Among older adults, 31 (97%) patients experienced AEs of all grades, and only six patients had grade ≥ 3 AEs with no grade 5 AEs. Afatinib demonstrated comparable therapeutic efficacy and safety in older and non-older adult patients with advanced EGFR-mutant NSCLC.

Trial registration: UMIN-CTR identifier (UMIN000024935)